Source of the article: Siyu MedTech; Editor: Qi Yuan
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On July 18, 2024, the official website of the National Medical Products Administration (NMPA) released information showing that it has approvedSonosemi Medical Co., Ltd."Portable Ultrasound Diagnostic Device"And"Single-Use Intracardiac Ultrasound Imaging Catheter"Two Innovative Product Registration Applications。
SONOSEMI's self-developed Intracardiac Echocardiography System (ICE)May 26, 2023Approved to enter the National Medical Products Administration (NMPA) special review process for innovative medical devices, this product isThe First China-Made ICE Product Approved to Enter the Innovation Fast Track in China。SONOSEMI's Intracardiac Echocardiography (ICE) System consists of the UDG3900 Color Doppler Ultrasound Diagnostic System and the DynaSight 2D Single-Use Intracardiac Echocardiography Catheter. It is suitable for intracardiac and large vessel imaging, as well as ultrasound imaging of other devices within the heart.
The portable ultrasound diagnostic instrument consists of an ultrasound host, a connector, and a power adapter.The single-use intracardiac echocardiography imaging catheter is composed of a catheter tip, a deflectable tube, an operating handle, and a rear connector. It utilizes the inverse piezoelectric effect to convert pulse electrical signals output by a portable ultrasound diagnostic device into ultrasonic waves that are emitted into the heart cavity tissue. It also receives echo signals and transmits them back to the portable ultrasound diagnostic device, which converts them into digital image signals for display on a monitor.The combination of the two products is used for ultrasound imaging of adult cardiac, major cardiac vessels, and intracardiac anatomical structures. Compared with similar products, it offers greater detection depth and is China's first intracardiac ultrasound imaging system.# Overview of Intracardiac Echocardiography (ICE)
Intracardiac Echocardiography (ICE)It refers to installing a miniature transducer at the tip of a cardiac catheter, which is then delivered through peripheral blood vessels (veins) into the heart chamber. The transducer emits sound waves, and the returning echoes are processed by a computer to form ultrasound images. This technique provides high-resolution, real-time imaging of the heart's internal anatomy, other intracardiac catheters, and devices, as well as real-time monitoring of hemodynamic status. It is not obstructed by surrounding structures such as ribs and does not require general anesthesia.
In recent years, ICE has been increasingly applied inIntraoperative Monitoring for Cardiac Electrophysiology Treatment, Minimally Invasive Valve Disease Treatment, Cardiac Pacing Treatment, and Congenital Heart Disease Occlusion Treatmentand other fields, while also playing an increasingly important role in the preoperative diagnosis of complex structural heart disease.The most maturely applied field currently is arrhythmia.Traditional electrophysiological treatment mainly relies on X-ray fluoroscopy and electrophysiological mapping catheters for positioning. Due to the inability to fully and clearly provide the internal anatomical structure of the heart, it can easily lead to perioperative complications such as cardiac tamponade and pulmonary vein stenosis, with a relatively high recurrence rate. Intracardiac echocardiography (ICE) can place the catheter probe in the right atrium or right ventricle, providing real-time, clear images of the left atrium, left ventricle, and the openings of the pulmonary veins, allowing surgeons to precisely locate ablation targets.According to incomplete statistics, as of now, global device giantsSiemens, Philips, GE Healthcare, Johnson & Johnson, Abbott, Boston Scientificand others have already laid out intracardiac ultrasound.
Currently, there are mainly three imported ICE products (from companies including Johnson & Johnson, Abbott, and Siemens) and one domestically produced ICE product (by TingSheng Technology) approved in China. Most of the domestically produced ICE products are still in the research and clinical stages, primarily focusing on 2D products. 4D ICE has extremely high technical barriers, and only a few companies in China have truly ventured into this area.
From the perspective of 4D ICE systems, Philips and Johnson & Johnson were successively approved for listing abroad in 2021, and quickly began the commercialization process; the industry expects imported 4D ICE products to enter the Chinese market as early as 2024.
Overall, the 4D ICE market is still in its infancy.From the perspective of the 4D ICE layouts by a very few companies in China, domestically produced and imported related products are expected to achieve synchronized market launch, together dividing the unmet clinical needs.
# ICE Product Layout in China
1. China's First Self-Developed ICE Product: TINGSN Sonic Eyes 10 by TingSheng TechnologyAs the first domestically produced intracardiac echocardiography catheter approved in China (November 2023), TINGSN Sonic Eyes 10, developed by TingSheng Technology, consists of a catheter body, an operating handle, and a connector. When paired with the company's portable color ultrasound diagnostic system, it is suitable for medical institutions to perform ultrasound imaging of the heart, major cardiac vessels, and intracardiac anatomical structures.
The product features four-way bending control, segmented design, real-time temperature detection, and multi-frequency switching between 4.5MHz and 9.5MHz.While completing the smooth approval of the 2D ICE, TingSheng Technology is accelerating the development of its 4D ICE intracardiac ultrasound product.
2. XinHuan Technology 2D, 4D ICE ProductsSONOSEMI currently offers 2D and 4D ICE products. The 2D ICE system features the world's thinnest ultrasound catheter size, approaching the industry's technological limits, which will help minimize complications caused by puncture injuries and provide patients with a high-quality ICE solution made in China. This system has now entered the clinical trial registration stage.The 4D ICE system integrates multiple cutting-edge ultrasound imaging technologies, such as soft beamforming and arbitrary waveform transmission, which can effectively reduce the risks of cardiac interventional procedures and shorten the learning curve for operators.▲CardioViz 4D ICE Catheter
3. Ice Crystal Intelligence: Full-line Layout of ICE Product LineIce Crystal Intelligence is the only manufacturer in China that has fully laid out 2D, HD, 3D, and 4D ICE product lines for cardiac interventional procedures. To meet the usage requirements of different clinical scenarios, the company has developed the next-generation high-definition and high-speed intracardiac echocardiography (HD-ICE). The product adopts an industry-first new-generation acoustic energy conversion system, which can effectively improve signal acquisition, transmission efficiency, and image clarity. At the same time, the HD-ICE system uses China's first dedicated high-definition cardiac image processing system, applying the latest algorithm technology in the industry to achieve faster imaging speed, thereby meeting more clinical needs.In the field of 4D ICE, Ice Crystal Intelligence has adopted the internationally mainstream electronic matrix transducer technology solution and correspondingly utilized high-speed volumetric reconstruction algorithms. This solution offers a significant advantage in imaging speed compared to mechanical volumetric imaging solutions, allowing for more real-time observation of heart valve movements. It holds a natural advantage for procedures with extremely high real-time requirements, such as mitral valve clipping. Relevant test samples have already been developed and are currently being prepared for further animal experiments.
SONOSEMIFounded in April 2020, headquartered in Shenzhen, is a research and productionActive Vascular Implantable Medical Deviceshigh-tech enterprise, with main businesses coveringCardio-cerebrovascular, Peripheral VascularIn the medical field represented by, the products includeShockwave Balloon Catheter, Ultrasonic CatheterIncluding active interventional high-value medical consumables, the products coverCoronary artery disease, peripheral vascular disease, and structural heart diseaseIn the clinical fields of cardiovascular and cerebrovascular diseases.SONOSEMI has broken through the technical barriers of high-end medical devices overseas and independently developedCoronary Intravascular Shockwave Treatment System, Peripheral Arterial Intravascular Shockwave Treatment System, Intracardiac Ultrasound Imaging System, Intravascular UltrasoundThe innovative products in the field of pan-vascular active interventional treatments are expected to form a product matrix consisting of 4-6 products by the end of 2024, providing customers with comprehensive and integrated solutions.These products extensively cover indications such as coronary artery calcification, peripheral artery calcification, aortic valve stenosis, and structural heart disease.According to Tianyancha information, the actual controller of SONOSEMI is Liu Bin.SONOSEMI's co-founder and CEO, previously worked at Huawei Technologies, isHuawei EngineerBackground. With years of experience in communication and semiconductor technology research and application, he has a strong technical background in the industry and holds more than 20 invention patents. He is also a serial entrepreneur with extensive experience in technological innovation, team management, and commercial applications.Participated in the entrepreneurship of a semiconductor chip company, and through in-depth collaboration with partners in the medical field, quickly advanced the Shockwave Balloon, an active interventional product, into the clinical stage. A series of interventional visualization hardware products developed by the company will also obtain certifications successively thereafter. The company’s platform-based development strategy is very clear.
Editor-in-Chief | Zhao Qing Reviewed by | Yi He
